US8956397B2

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Publication number: US8956397B2
Application number: US13/519,971
Authority: US
Inventors: Alon Shalev; Sagi Raz
Original assignee: Endospan Ltd
Current assignee: Japan Lifeline Co Ltd
Priority date: 2009-12-31
Filing date: 2010-12-27
Publication date: 2015-02-17
Also published as: EP2519166A1; CA2785953C; CA2785953A1; WO2011080738A1; EP2519166A4; US20120316634A1

Abstract

An endovascular tool is provided, which includes a longitudinal delivery shaft and a fin coupled to the delivery shaft. The fin is configured to assume a compressed state for endoluminal delivery, and an expanded state for endoluminal deployment, in which state the fin is configured to pivot around an axis of rotation. Other embodiments are also described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present patent application is the U.S. national stage of International Application PCT/IL2010/001087, filed Dec. 27, 2010, which claims priority from US Provisional Application 61/291,427, filed Dec. 31, 2009, entitled, “Endovascular flow direction indicator and methods for using such,” which is incorporated herein by reference.

FIELD OF THE APPLICATION

This present application relates generally to surgical tools and methods, and specifically to endovascular surgical tools and techniques for implanting prostheses to maintain patency of body passages such as blood vessels, such as for treating aneurysms.

BACKGROUND OF THE APPLICATION

Endovascular prostheses are sometimes used to treat aortic aneurysms. Such treatment includes implanting a stent or stent-graft within the diseased vessel to bypass the anomaly. An aneurysm is a sac formed by the dilation of the wall of the artery. Aneurysms may be congenital, but are usually caused by disease or, occasionally, by trauma. Aortic aneurysms which commonly form between the renal arteries and the iliac arteries are referred to as abdominal aortic aneurysms (“AAAs”). Other aneurysms occur in the aorta, such as thoracic aortic aneurysms (“TAAs”) and aortic uni-iliac (“AUI”) aneurysms.

PCT Publication WO 2008/107885 to Shalev et al., and US Patent Application Publication 2010/0063575 to Shalev et al. in the US national stage thereof, which are incorporated herein by reference, describe a multiple-component expandable endoluminal system for treating a lesion at a bifurcation, including a self expandable tubular root member having a side-looking engagement aperture, and a self expandable tubular trunk member comprising a substantially blood impervious polymeric liner secured therealong. Both have a radially-compressed state adapted for percutaneous intraluminal delivery and a radially-expanded state adapted for endoluminal support.

The following references may be of interest:

U.S. Pat. No. 4,938,740 to Melbin

U.S. Pat. No. 5,824,040 to Cox et al.

U.S. Pat. No. 7,044,962 to Elliott

U.S. Pat. No. 7,544,160 to Gross

US Patent Application Publication 2006/0229709 to Morris et al.

US Patent Application Publication 2006/0241740 to Vardi et al.

US Patent Application Publication 2008/0109066 to Quinn

PCT Publication WO 09/118,733 to Karasik

PCT PublicationWO 10/031,060 to Tuval et al.

SUMMARY OF APPLICATIONS

Some applications of the present invention provide an endovascular tool useful for aligning an imaging system, in order to facilitate properly aligning an implantable medical device, such as a vascular stent. The endovascular tool comprises a longitudinal delivery shaft and a fin coupled to the delivery shaft. The fin is configured to assume a compressed state for endoluminal delivery, and an expanded state for endoluminal deployment, in which state the fin is configured to pivot around an axis of rotation. The fin is configured such that, when the fin is placed in a blood flow path, at least a portion of the fin pivots in a direction that is indicative of a direction of blood flow in a vicinity of the fin.

For some applications, the fin is endoluminally deployed in one or more blood vessels of a subject, such as in the left and right common iliac arteries in a vicinity of a bifurcation with the descending abdominal aorta. The endovascular tool is endoluminally introduced into the one or more blood vessels while the fin is in its compressed state, typically in an outer shaft. The outer shaft is withdrawn proximally, thereby delivering the fin from the outer shaft, and transitioning the fin to its expanded state.

In its expanded state, the fin is configured to pivot around the axis of rotation, as described above. When the fin is thus placed in a blood flow path (such as blood flow downstream from the descending abdominal aorta into the iliac arteries), at least a portion of the fin pivots in a direction that is indicative of the direction of blood flow in the vicinity of the fin. The tool is positioned such that the axis of rotation is generally perpendicular to the direction of blood flow in the vicinity of the axis of rotation.

A radiographic image (such as a fluoroscopy image) of the fin is generated using an imaging system. The image is used to align an image plane of the imaging system generally parallel to a plane defined by the fin that is indicative of the direction of blood flow in the vicinity of the fin. This plane is defined by (a) the axis of rotation of the fin and (b) a vector oriented in the direction that the fin extends from the axis of rotation.

In order to align the image plane of the imaging system, a spatial attitude of a component of the imaging system (such as a C-arm) is changed (sometimes repeatedly), responsively to the radiographic image, until the image plane is generally parallel to the plane indicative of the direction of the blood flow in the vicinity of the fin.

For some applications, in order to align the image plane, after generating the image, one or more apparent dimensions of the fin as shown in the image are assessed, and the spatial attitude of the component of the imaging system is changed responsively to the assessing. In general, the fin will appear with a modified aspect ratio in the image to the extent that the image plane is not parallel with the plane indicative of the direction of blood flow in the vicinity of the fin. The spatial attitude of the component of the imaging system is adjusted until the fin appears to have its actual aspect ratio, indicating that the image plane and plane indicative of the direction of blood flow in the vicinity of the fin are parallel. In other words, the spatial attitude of the component of the imaging system is adjusted until an apparent shape of the fin (either of the entire fin, or of a portion thereof, such as one or more radiographic markers thereof), as shown in the radiographic image, is no longer distorted (e.g., no longer has a modified aspect ratio) compared to an actual shape of the fin, (e.g., appears to have its actual aspect ratio). Typically, the assessing and changing of the spatial attitude are repeated until a desired relationship has been obtained between the apparent dimensions and the actual dimensions of the fin.

After the imaging system has been properly aligned, the delivery shaft and the fin are withdrawn from the patient. Typically, the fin is first transitioned back to its compressed state, by retracting the fin into the outer shaft, by either advancing the outer shaft distally, and/or withdrawing the delivery shaft proximally.

A medical device, such as a stent (which, optionally, comprises a stent-graft), is introduced into vasculature of the subject, typically the one or more blood vessels from which the fin was withdrawn, or one or more other blood vessels in a vicinity of the one or more blood vessels from which the fin was withdrawn. The medical device is oriented using one or more images generated by the imaging system. Because the imaging system is properly aligned, as described above, the medical device can be properly aligned using images generated by the imaging system.

For some applications, the medical device, e.g., the stent, is rotationally oriented using the one or more images generated by the imaging system. For example, the stent may be shaped so as to define a lateral opening, and the lateral opening may be rotationally oriented using the imaging system, such as to face in a direction that is parallel to the image plane. If the imaging plane of the imaging system were not properly aligned as described above, the lateral opening would not be properly rotated to face the descending abdominal aorta, but instead would face another direction parallel to the misaligned imaging plane. Without the use of the alignment technique described herein, the imaging plane is sometimes misaligned with the plane indicative of the direction of blood flow by up to about 20 degrees, which results in the lateral opening being misaligned with the bifurcation with the descending abdominal aorta by up to about 20 degrees.

For some applications, the fin comprises a structural member and at least one substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member. Typically, the fin is at least partially radiopaque, in order to facilitate radiographic imaging of the fin.

For some applications, the fin extends laterally from a portion of the delivery shaft, and a longitudinal axis of the portion coincides with the axis of rotation of the fin.

For some applications, the fin is shaped so as to define one or more pivot joints, which rotatably couple the fin to the portion of the delivery shaft. Typically, the pivot joints are configured to facilitate at least 180 degrees of rotation of the fin around the delivery shaft, at least when the fin is in its expanded state. Typically, the pivot joints and the delivery shaft are configured to facilitate low-friction rotation of the fin around the delivery shaft, at least when the fin is in its expanded state.

For some applications, the fin has a substantially planar shape when in its expanded state. For example, the substantially planar shape may be a parallelogram, a rectangle, a square, a semicircle, a trapezoid, a shape defined by a curved segment having ends connected by a straight line, or a shape defined by an arc having ends connected by a straight line.

For some applications, the endovascular tool is used to treat an aneurysm, such as an aortic aneurism, or an aneurism of another blood vessel. For example, the aneurism may be of the sub-renal aorta.

There is therefore provided, in accordance with an application of the present invention, apparatus including an endovascular tool, which includes:

a longitudinal delivery shaft; and

a fin, which is coupled to the delivery shaft, and which is configured to assume (a) a compressed state for endoluminal delivery, and (b) an expanded state for endoluminal deployment, in which state the fin is configured to pivot around an axis of rotation.

Typically, the fin is configured such that, when the fin is placed in a blood flow path, at least a portion of the fin pivots in a direction that is indicative of a direction of blood flow in a vicinity of the fin.

For some applications, the fin is pivotable to rotate at least 180 degrees around the axis of rotation, at least when the fin is in its expanded state.

For some applications, the delivery shaft has a length of at least 10 cm.

For some applications, the fin, at least when in its expanded state, extends laterally from a portion of the delivery shaft, and a longitudinal axis of the portion coincides with the axis of rotation. For some applications, the longitudinal axis of the portion of the delivery shaft substantially lies within a plane generally defined by the fin when in its expanded state. For some applications, the fin includes a structural member and a substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member, and the longitudinal axis of the portion of the delivery shaft substantially lies within a plane generally defined by the membrane member when the fin is in its expanded state.

For some applications, the fin is shaped so as to define one or more pivot joints, which rotatably couple the fin to the portion of the delivery shaft. For some applications, each of the one or more pivot joints is shaped so as to surround at least 210 degrees of the delivery shaft. For some applications, the pivot joints are configured to facilitate at least 180 degrees of rotation of the fin around the delivery shaft, at least when the fin is in its expanded state. For some applications, the pivot joints and the delivery shaft are configured to facilitate low-friction rotation of the fin around the delivery shaft, at least when the fin is in its expanded state. For some applications, the pivot joints and the delivery shaft are configured to provide a coefficient of static friction between the pivot joints and the delivery shaft of no more than 0.5. For some applications, the pivot joints and the delivery shaft are configured such that the pivot joints rotate with respect to the delivery shaft even when the fin is positioned in a blood flow of a healthy peripheral artery having a diameter of at least 3 mm in a subject having a systolic to diastolic blood pressure gradient of at least 30 mmHg. For some applications, at least one of the pivot joints (e.g., exactly one of the pivot joints, or two or more of the pivot joints) is axially fixed to the delivery shaft so as to prevent axial motion of the at least one of the pivot joints with respect to the delivery shaft.

For some applications, the fin includes a structural member and at least one substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member, and the structural member is shaped so as to define the one or more pivot joints. For some applications, the fin includes a structural member and at least one substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member, and the membrane member is shaped so as to define the one or more pivot joints.

For some applications, the portion of the delivery shaft has first and second ends from which respective first and second portions of the fin extend in a same radial direction from the longitudinal axis.

For some applications, the endovascular tool further includes a support structure, which is coupled to the delivery shaft, and the fin is coupled to the support structure, so as to be indirectly coupled to the delivery shaft.

For some applications, the endovascular tool includes exactly one fin.

For some applications, the fin is at least partially radiopaque. For some applications, the fin includes a structural member, and a plurality of radiopaque markers, which are fixed to the structural member, and which have a greater radiopacity per unit weight than that of the structural member.

For some applications, the fin includes a structural member and at least one substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member. For some applications, the structural member includes a super-elastic material, such as a super-elastic metal alloy, e.g., Nitinol. For some applications, the flow-resistant membrane member includes an implantable-grade polymer, such as polytetrafluoroethylene (PTFE), e.g., expanded polytetrafluoroethylene (ePTFE). Alternatively, for some applications, the polymer includes a polyester. For some applications, the at least one membrane member has a surface area of between 9 and 50 mm2 when the fin is in its expanded state.

For some applications, a length of the delivery shaft is at least 10 times a greatest dimension of the fin measured in a direction parallel with the axis of rotation when the fin is in its expanded state.

For some applications, the fin has a substantially planar shape when in its expanded state. For example, the substantially planar shape may be selected from the group of shapes consisting of: a parallelogram, a rectangle, a square, a semicircle, a trapezoid, a shape defined by a curved segment having ends connected by a straight line, and a shape defined by an arc having ends connected by a straight line. For some applications, the fin has an airfoil shape when in its expanded state. For some applications, the fin is generally cylindrical when in its expanded state.

For any of the applications described above, the apparatus may further include a generally tubular outer shaft, in which the delivery shaft is at least partially positioned, and in which the fin is initially positioned in its compressed state at least partially alongside the delivery shaft. For some applications, the outer shaft, the delivery shaft, and the fin are configured such that longitudinal translation of the outer shaft with respect to the delivery shaft (a) in a first axial direction effects a transition of the fin from its compressed state to its expanded state, and (b) in a second axial direction opposite the first axial direction effects a transition of the fin from its expanded state to its compressed state. Alternatively, for some applications, the outer shaft, the delivery shaft, and the fin are configured such that rotation of the outer shaft with respect to the delivery shaft (a) in a first rotational direction effects a transition of the fin from its compressed state to its expanded state, and (b) in a second rotation direction opposite the first rotation direction effects a transition of the fin from its expanded state to its compressed state.

For any of the applications described above, the apparatus may further include an endovascular guidewire, and the delivery shaft is shaped so as to define a longitudinal bore therethrough, which is configured to allow deployment of the delivery shaft over the guidewire.

There is further provided, in accordance with an application of the present invention, a method including:

providing an endovascular tool including a longitudinal delivery shaft and a fin coupled to the delivery shaft;

endoluminally introducing the endovascular tool into one or more blood vessels of a subject while the fin is in a compressed state; and

thereafter, transitioning the fin to an expanded state, in which state the fin is configured to pivot around an axis of rotation.

For some applications, the method further includes, after transitioning, generating a radiographic image of the fin using an imaging system. For some applications, the method further includes changing a spatial attitude of a component of the imaging system, responsively to the radiographic image, such that an image plane of the imaging system is generally parallel to a plane defined by the fin that is indicative of a direction of blood flow in a vicinity of the fin.

For some applications, the method further includes changing a spatial attitude of a component of the imaging system until an apparent shape of the fin, as shown in the radiographic image, no longer has a modified aspect ratio compared to its actual aspect ratio.

For some applications, the method further includes, after changing the spatial attitude:

withdrawing the endovascular tool;

introducing a medical device into vasculature of the subject; and

orienting the medical device using one or more images generated by the imaging system.

For some applications, orienting include rotationally orienting the medical device.

For some applications, the medical device is a stent, and introducing and orienting includes introducing and orienting the stent. For some applications, the stent is shaped so as to define a lateral opening, and orienting the stent includes orienting the lateral opening. For some applications, orienting the lateral opening includes orienting the lateral opening to face in a direction that is parallel to the image plane. For some applications, the stent includes two or more radiopaque features distributed around the lateral opening, and orienting the lateral opening includes orienting the lateral opening such that at least a portion of the radiopaque features are aligned with one another in the one or more images.

For some applications:

the delivery shaft is shaped so as to define a longitudinal bore therethrough,

endoluminally introducing the endovascular tool includes endoluminally introducing a guidewire into the one or more blood vessels, and advancing the delivery shaft over the guidewire such that the guidewire passes through the bore,

withdrawing the endovascular tool includes leaving the guidewire in the one or more blood vessels, and

introducing the medical device includes introducing the medical device over the guidewire.

For some applications, endoluminally introducing includes positioning the fin in a vicinity of a bifurcation between at least two blood vessels. For some applications, endoluminally introducing includes positioning the delivery shaft in the one or more blood vessels such that the fin is aligned with the bifurcation. For some applications, positioning the delivery shaft includes positioning two portions of the delivery shaft in left and right common iliac arteries, respectively.

For some applications, the method further includes identifying that the patient suffers from an aneurysm, and endoluminally introducing includes endoluminally introducing the endovascular tool responsively to the identifying.

For some applications, transitioning includes transitioning the fin to its expanded state in which the fin extends laterally from a portion of the delivery shaft, and a longitudinal axis of the portion coincides with the axis of rotation. For some applications, providing the endovascular tool includes providing the endovascular tool in which the fin is shaped so as to define one or more pivot joints, which rotatably couple the fin to the portion of the delivery shaft.

For some applications, providing the endovascular tool includes providing the endovascular tool further including a support structure, which is coupled to the delivery shaft, and the fin is coupled to the support structure, so as to be indirectly coupled to the delivery shaft.

For some applications, providing the endovascular tool includes providing the endovascular tool including exactly one fin.

For some applications, providing the endovascular tool includes providing the endovascular tool in which the fin is at least partially radiopaque.

For some applications, providing the endovascular tool includes providing the endovascular tool in which the fin includes a structural member and at least one substantially flow-resistant membrane member, which is securely mounted to at least a portion of the structural member.

For some applications, transitioning includes transitioning the fin to its expanded in which state the fin has a substantially planar shape. For example, the substantially planar shape may be selected from the group of shapes consisting of: a parallelogram, a rectangle, a square, a semicircle, a trapezoid, a shape defined by a curved segment having ends connected by a straight line, and a shape defined by an arc having ends connected by a straight line.

For some applications, providing the endovascular tool includes providing the endovascular tool further including a generally tubular outer shaft, and endoluminally introducing includes endoluminally introducing the outer shaft in which the delivery shaft is at least partially positioned, and in which the fin is initially positioned in its compressed state at least partially alongside the delivery shaft. For some applications, transitioning the fin to its expanded state includes longitudinally translating the outer shaft with respect to the delivery shaft in a first axial direction, and further including subsequently longitudinally translating the outer shaft with respect to the delivery shaft in a second axial direction opposite the first axial direction to effect a transition of the fin from its expanded state to its compressed state. Alternatively, for some applications, transitioning the fin to its expanded state includes rotating the outer shaft with respect to the delivery shaft in a first axial direction, and further including subsequently rotating the outer shaft with respect to the delivery shaft in a second axial direction opposite the first axial direction to effect a transition of the fin from its expanded state to its compressed state.

The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-C are schematic illustrations of an endovascular tool in compressed, partially-expanded, and expanded states, respectively, in accordance with an application of the present invention;

FIGS. 2A-B are schematic illustrations of another configuration of the endovascular tool ofFIGS. 1A-C in compressed and expanded states, respectively, in accordance with an application of the present invention;

FIG. 3 is a schematic illustration of yet another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIG. 4 is a schematic illustration of still another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIG. 5 is a schematic illustration of another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIG. 6 is a schematic illustration of yet another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIG. 7 is a schematic illustration of another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIG. 8 is a schematic illustration of yet another configuration of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with an application of the present invention;

FIGS. 9A-C are schematic illustrations of respective configurations of the endovascular tool ofFIGS. 1A-C in an expanded state, in accordance with respective applications of the present invention; and

FIGS. 10A-F are schematic illustrations of an exemplary transluminal procedure performed using the endovascular tool ofFIGS. 1A-C, in accordance with an application of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

FIGS. 1A-C are schematic illustrations of anendovascular tool10 in compressed, partially-expanded, and expanded states, respectively, in accordance with an application of the present invention.Endovascular tool10 typically comprises alongitudinal delivery shaft24 and afin20 coupled to the delivery shaft. The fin is configured to assume (a) a compressed state for endoluminal delivery (and, optionally, retrieval), as shown inFIG. 1A, and (b) an expanded state for endoluminal deployment, in which state the fin is configured to pivot around an axis ofrotation18, such as shown inFIG. 1C.Fin20 typically assumes its compressed state when positioned a generally tubularouter shaft22 at least partially alongsidedelivery shaft24, initially before deployment of the fin, as described hereinbelow with reference toFIG. 10B, and, optionally, again subsequently to performing a calibrationprocedure using tool10.FIG. 1B shows the fin in an intermediate, partially-expanded state, in which the fin is partially deployed fromouter shaft22. Typically,tool10 comprises exactly onefin20; alternatively,tool10 comprises two or more fins (configuration not shown).

For some applications,fin20 is relaxed in its expanded state. For some applications, the fin is configured to be self-expanding. For example, the fin may be heat-set to assume its expanded state. For some applications,fin20 is configured to assume the compressed state when constrained (such as when within outer shaft22), and to assume the expanded state when relaxed.

As described in more detail hereinbelow with reference toFIGS. 10C-D,fin20 is configured such that, when the fin is placed in a blood flow path, at least a portion of the fin pivots in a direction that is indicative of the direction of blood flow in a vicinity of the fin.

Typically,fin20 is pivotable to rotate at least 180 degrees around axis ofrotation18, as schematically indicated by anarrow26 inFIG. 1C, at least when the fin is in its expanded state.

For some applications,fin20 comprises astructural member32 and at least one substantially flow-resistant membrane member34, which is securely mounted to at least a portion of the structural member, either directly or indirectly, such as by a plurality ofcoupling elements36, e.g., sutures or threads. For some applications,structural member32 comprises a super-elastic material, such as a super-elastic metal alloy, e.g., Nitinol.Membrane member34 typically comprises a thin pliable sheet of material, which may, for example, comprise an implantable-grade polymer, such as polytetrafluoroethylene (PTFE), e.g., expanded polytetrafluoroethylene (ePTFE), a polyester, or a textile material (e.g., polyethylene terephthalate (PET)). For some applications,membrane member34 has a surface area of at least 9 mm2, no more than 50 mm2, and/or between 9 and 50 mm2.

For some applications, as shown inFIG. 1A-C (andFIGS. 2A-B,3,4,5,6,8,9A-C, and10A-F, described hereinbelow),fin20 extends laterally from aportion28 ofdelivery shaft24, and a longitudinal axis ofportion28 coincides with axis ofrotation18. For these applications, the longitudinal axis ofportion28 typically substantially lies within aplane29 generally defined byfin20 and/ormembrane member34 when the fin is in its expanded state, as shown in the side-view blow-up inFIG. 1C. Typically,portion28 has first and second ends from which respective first and second portions offin20 extend in a same radial direction fromlongitudinal axis18, for example, the direction indicated by a vector V inFIG. 1C. For other applications, such as described hereinbelow with reference toFIG. 7, axis ofrotation18 does not coincide with a longitudinal axis ofdelivery shaft24.

For some applications, fin20 (typically,structural member32 and/or membrane member34) is shaped so as to define one or more pivot joints38, which rotatably couple the fin toportion28 ofdelivery shaft24. For example, the pivot joints may include exactly two

pivot joints

38A and38B, such as shown inFIGS. 1A-C (andFIGS. 3-6, described hereinbelow). Alternatively, exactly one pivot joint may be provided, such as shown inFIG. 8, or more than two pivot joints may be provided, such as shown inFIGS. 2A-B, described hereinbelow. Typically, each of pivot joints38 is shaped so as to surround at least 210 degrees ofdelivery shaft24, such as at least 270 degrees, or 360 degrees (i.e., entirely surround the shaft), in order to be coupled to the delivery shaft. Typically, pivot joints38 are configured to facilitate at least 180 degrees of rotation of the fin around the delivery shaft, as indicated byarrow26 inFIG. 1C, at least when the fin is in its expanded state.

Typically, pivot joints38 anddelivery shaft24 are configured to facilitate low-friction rotation offin20 around the delivery shaft, at least when the fin, is in its expanded state. For example, the pivot joints and the delivery shaft may be configured to provide a coefficient of static friction between the pivots and the delivery shaft of no more than 0.5, such as no more than 0.2. Alternatively or additionally, the pivot joints and the delivery shaft may be configured such that the pivot joints rotate with respect to the delivery shaft even whenfin20 is positioned in a blood flow of a healthy peripheral artery having a diameter of at least 3 mm in a subject having a systolic to diastolic blood pressure gradient of at least 30 mmHg.

For some applications, at least one (e.g., exactly one, or two or more) of pivot joints38 is axially fixed todelivery shaft24 so as to prevent axial motion of the at least one of the pivots with respect to the delivery shaft. Such fixation may aid in deployment offin20 fromouter shaft22, such as described hereinbelow with reference toFIG. 10C.

For some applications,fin20 has a substantially planar shape when in its expanded state. For example, the substantially planar shape may be a parallelogram, a rectangle (such as shown inFIGS. 2B,3, and4), a square, a semicircle, a trapezoid, a shape defined by a curved segment having ends connected by a straight line (such as shownFIGS. 1C and 6), or a shape defined by an arc having ends connected by a straight line.

For other applications,fin20 has an airfoil shape (e.g., a symmetrical airfoil) when in its expanded state (configuration not shown). For still other applications,fin20 is generally cylindrical when in its expanded state, such as described hereinbelow with reference toFIG. 8.

For some applications, a length ofdelivery shaft24 is at least 10 times, such as at least 20 times a greatest dimension D1 offin20 measured in a direction parallel with axis ofrotation18, when the fin is in its expanded state, as shown inFIG. 1C. For some applications, greatest dimension D1 is at least 3 mm, no more than 30 mm, and/or between 3 and 30 mm. For some applications, a greatest dimension D2 offin20 measured in a direction parallel with axis ofrotation18, when the fin is in its compressed state, is at least 5 mm, no more than 50 mm, and/or between 5 and 50 mm, as shown inFIG. 1A. For some applications,delivery shaft24 has a length of at least 10 cm, such as at least 50 cm.

For some applications,fin20 has a greatest length L1 in a direction perpendicular to axis ofrotation24 when the fin is in its expanded state, which greatest length is at least 3 mm, no more than 15 mm, and/or between 3 and 15 mm, as shown inFIG. 1C. For some applications,fin20 has a greatest length L2 in a direction perpendicular to axis ofrotation24 when the fin is in its compressed state, which greatest length is at least 1.5 mm, no more than 4 mm, and/or between 1.5 and 4 mm, as shown inFIG. 1A. For some applications, greatest length L1 (when the fin is in its expanded state) is at least 200% greater than greatest length L2 (when the fin is in its compressed state).

For some applications, an axial length L3 offin20 along axis ofrotation18 is at least 6 mm, no more than 20 mm, and/or between 6 and 20 mm when the fin is in its expanded state, as shown inFIG. 1C. (For some applications, greatest dimension D1 may be greater than axial length L3, when the greatest dimension does not coincide with axis ofrotation18.) For some applications, an axial length L4 offin20 along axis ofrotation18 is at least 10 mm, no more than 40 mm, and/or between 10 and 40 mm when the fin is in its compressed state, as shown inFIG. 1A. For some applications, axial length L4 (when the fin is in its compressed state) is at least 50% greater than axial length L3 (when the fin is in its expanded state).

For some applications,outer shaft22,delivery shaft24, andfin20 are configured such that longitudinal translation of the outer shaft with respect to the delivery shaft (a) in a first axial direction (e.g., translation of the outer shaft to the left inFIGS. 1A-C) effects a transition of the fin from its compressed state (such shown inFIG. 1A) to its expanded state (such as shown inFIG. 1C), and (b) in a second axial direction opposite the first axial direction effects a transition of the fin from its expanded state to its compressed state. In other words, the fin is configured to be capable of being compressed by the outer shaft when withdrawn into the outer shaft.

For some applications,outer shaft22,delivery shaft24, andfin20 are configured such that rotation of the outer shaft with respect to the delivery shaft (a) in a first rotational direction effects a transition of the fin from its compressed state to its expanded state, and (b) in a second rotation direction opposite the first rotation direction effects a transition of the fin from its expanded state to its compressed state. For example,outer shaft22 anddelivery shaft24 may be shaped so as to define a threading therebetween.

For some applications, anendovascular guidewire30 is provided.Delivery shaft24 is shaped so as to define a longitudinal bore therethrough, which is configured to allow deployment of the delivery shaft over the guidewire.

Reference is now made toFIGS. 2A-B, which are schematic illustrations of another configuration ofendovascular tool10 in compressed and expanded states, respectively, in accordance with an application of the present invention. Except as described below, this configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIGS. 1A-C.

For some applications, as shown inFIGS. 2A-B, fin20 (typically,structural member32 and/or membrane member34) is shaped so as to define threepivot joints38, which rotatably couple the fin toportion28 ofdelivery shaft24. First and second ones of these pivot joints (38A and38B) extend to respective axial ends ofportion28 ofdelivery shaft24, and a third one of the pivot joints (38C) is positioned between first and

second pivot joints

38A and38B.

For some applications, as shown inFIGS. 2A-B,structural member32 is shaped so as to define all three

pivot joints

38A,38B, and38C. Optionally, pivot joint38C is not directly coupled to the remainder ofstructural member32. Typically,membrane member34 is coupled to the portion ofstructural member32 that defines pivot joint38C (such as by coupling elements36), as well as to the portion ofstructural member32 that defines

pivot joints

38A and38B.

Althoughfin20 is shown inFIG. 2B as having the shape of a rectangle when in its expanded state, the fin may alternatively have another shapes, such as the shapes described hereinabove with reference toFIGS. 1A-C, and/or shown in any of the other figures.

One or more of the features of the configuration offin20 described with referenced to and/or shown inFIGS. 2A-B may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,3,4,5,6,7,8, and/or9A-C.

Reference is now made toFIG. 3, which is a schematic illustration of yet another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. This configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIGS. 2A-B, except thatfin20 comprises only first and

second pivot joints

38A and38B, and not third pivot joint38C. One or more of the features of the configuration offin20 described with referenced to and/or shown inFIG. 3 may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,2A-B,4,5,6,7,8, and/or9A-C.

Reference is now made toFIG. 4, which is a schematic illustration of still another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. Except as described hereinbelow with reference toFIGS. 1A-C and2-7, this configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIG. 3.

One or more of the features of the configuration offin20 described with referenced to and/or shown inFIG. 4 may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,2A-B,3,5,6,7,8, and/or9A-C.

Reference is now made toFIG. 5, which is a schematic illustration of another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. Except as described below, this configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIG. 4. In this configuration,structural member32 is shaped so as to define one ormore loops42. These loops may serve to reduce kinking in at least one corner of the structural member, when the fin is folded intoouter shaft22.

One or more of the features of the configuration offin20 described with referenced to and/or shown inFIG. 5 may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,2A-B,3,4,6,7,8, and/or9A-C.

Reference is now made toFIG. 6, which is a schematic illustration of yet another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. Except as described below, this configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIGS. 1A-C. In this

configuration pivot joints

38A and38B come nearly in contact with each other alongdelivery shaft24 when the fin is in its expanded state, such as within 2 mm of each other.

One or more of the features of the configuration offin20 described with referenced to and/or shown inFIG. 6 may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,2A-B,3,4,5,7,8, and/or9A-C.

Reference is now made toFIG. 7, which is a schematic illustration of another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. Except as described below, this configuration oftool10 is generally similar to the configuration described hereinabove with reference toFIGS. 1A-C.

In this configuration,endovascular tool10 further comprises asupport structure50, which is coupled todelivery shaft24. For some applications,support structure50 is rotationally fixed with respect to the delivery shaft and/or axially-fixed to the delivery shaft to prevent axial motion of the support structure with respect to the shaft. Alternatively, the support structure is only axially fixed to the shaft, only rotationally fixed to the shaft, or neither axially fixed nor rotationally fixed to the shaft.Fin20 is coupled to supportstructure50, so as to be indirectly coupled todelivery shaft24.Fin20 is configured to pivot around axis ofrotation18, which, in this configuration, does not coincide with the longitudinal axis ofportion28 ofdelivery shaft24. For some applications, axis ofrotation18 coincides with an axis of a portion ofsupport structure50, such as shown inFIG. 7. For some applications, axis ofrotation18 is generally parallel with the longitudinal axis ofportion28 ofdelivery shaft24, such as shown inFIG. 7. For other applications, the axis of rotation is not generally parallel with the longitudinal axis of portion28 (configuration not shown).

One or more of the features of the configuration offin20 described with referenced to and/or shown inFIG. 7 may be implemented in combination with the features offin20 described with reference to and/or shown inFIGS. 1A-C,2A-B,3,4,5,8, and/or9A-C.

Reference is again made toFIGS. 1A-C and2-7. For some applications, respective portions ofstructural member32 that define

pivot joints

38A and38B have respective ends44. For some applications, as shown inFIGS. 1A-C,2A-B,3,6, and7, ends44 face in axially-opposite directions along axis ofrotation18. For some of these applications, such as shown inFIGS. 1A-C,6, and7, ends44 face axially toward each other along axis ofrotation18, while for others of these applications, such as shown inFIGS. 2A-B and3, ends44 face axially away from each other along axis of rotation18 (this configuration may facilitate retraction of the fin into outer shaft22). For other applications, such as shown inFIGS. 4 and 5, ends44 face in the same axial direction along axis ofrotation18.

Reference is now made toFIG. 8, which is a schematic illustration of yet another configuration ofendovascular tool10 in an expanded state, in accordance with an application of the present invention. In this configuration,fin20 is generally cylindrical when in its expanded state. For some applications, a central axis of thefin20 is generally parallel to axis ofrotation18, as shown inFIG. 8, while for other applications, the central axis of the fin is generally perpendicular to the axis of rotation (configuration not shown).

Reference is made toFIGS. 9A-C, which are schematic illustrations of respective configurations ofendovascular tool10 in an expanded state, in accordance with respective applications of the present invention. Typically,fin20 is at least partially radiopaque, in order to facilitate radiographic imaging of the fin, such as described hereinbelow with reference toFIG. 10D. For some applications,fin20 comprises a plurality ofradiopaque markers40, which are fixed tostructural member40, and have a greater radiopacity per unit weight than that of the structural member. For some applications, at least some ofradiopaque markers40 comprise small circular or semispherical elements, such as shown inFIG. 9A. Alternatively or additionally, at least some ofradiopaque markers40 comprise short tube segment, as shown inFIGS. 9B and 9C, which are wrapped around respective portions ofstructural member32. Alternatively or additionally, some or all ofradiopaque markers40 are fixed to membrane member34 (configuration not shown). AlthoughFIGS. 9A-C illustrateradiopaque markers40 applied to the configuration offin20 described hereinabove with reference toFIGS. 1A-C, the radiopaque markers may be similarly applied to the other configurations offin20 described herein, such as with reference toFIGS. 2A-B,3,4,5,6,7, and/or8.

Reference is now made toFIGS. 10A-F, which are schematic illustrations of an exemplary transluminal procedure performed usingendovascular tool10, in accordance with an application of the present invention. Although this procedure is illustrated using the configuration oftool10 described hereinabove with reference toFIGS. 1A-C, the procedure may also be used to deploy the other configurations oftool10 described herein, mutatis mutandis.

As shown inFIG. 10A, the exemplary procedures begins by endoluminally introducingguidewire30 into one or more blood vessels of a subject. For example,fin20 may be positioned in a vicinity of a bifurcation between at least two blood vessels, optionally aligned with the bifurcation, as shown inFIG. 10A. By way of example, inFIG. 10A the guidewire is shown introduced into left and right common

iliac arteries

100A and100B.

As shown inFIG. 10B,endovascular tool10 is endoluminally introduced into the one or more blood vessels whilefin20 is in its compressed state. Typically, in order to endoluminally introduce the tool,delivery shaft24 is passed overguidewire30 such that the guidewire passes through a bore defined by the delivery shaft, andouter shaft22 is also passed over the guidewire.Fin20 is initially positioned in its compressed state withinouter shaft22, typically near a distal end of the outer shaft. Althoughdelivery shaft24 is shown by way of illustration inFIG. 10B as extending slightly distally out of the distal end ofouter shaft22,delivery shaft24 does not necessarily extend out ofouter shaft22 at this stage of deployment.

Delivery shaft

24 andouter shaft22 are longitudinally translated with respect to each other, thereby deliveringfin20 from the outer shaft, and transitioningfin20 to its expanded state, as shown inFIG. 10C. For some applications, as shown, this relative longitudinal translation is effected by holdingdelivery shaft24 in place asouter shaft22 is withdrawn proximally. Alternatively, this relative longitudinal translation is effected by holdingouter shaft22 in place asdelivery shaft24 is advanced distally (technique not shown). As mentioned above with reference toFIGS. 1A-C, for some applications, at least one (e.g., exactly one, or two or more) of pivot joints38 is axially fixed todelivery shaft24 so as to prevent axial motion of the at least one of the pivots with respect to the delivery shaft. Such fixation may aid in deployment of the fin fromouter shaft22, by preventingfin20 from moving with respect toouter shaft22 as the delivery shaft and outer shaft are longitudinally translated with respect to each other.

In its expanded state, the fin is configured to pivot around the axis of rotation, as described hereinabove with reference toFIGS. 1A-C. When the fin is thus placed in a blood flow path (in this exemplary case, blood flow downstream from a descendingabdominal aorta102 into

iliac arteries

100A and100B), at least a portion of the fin pivots in a direction that is indicative of the direction of blood flow in the vicinity of the fin, as indicated by a vector V inFIG. 10C, perhaps best seen in Section A-A thereof.Tool10 is positioned such that axis of rotation18 (and, in the illustrated configuration,portion28 of delivery shaft24) is generally perpendicular to the direction of blood flow, in the vicinity of the axis of rotation.

As shown inFIG. 10D, a radiographic image (such as a fluoroscopy image) offin20 is generated using an imaging system120 (such as a fluoroscopy imaging system). The image is used to align an image plane ofimaging system120 generally parallel to aplane122 defined by the fin that is indicative of the direction of blood flow in the vicinity of the fin.Plane122 is defined by (a) axis of rotation18 (and, in the illustrated configuration,portion28 of delivery shaft24), and (b) vector V oriented in the direction thatfin20 extends from axis ofrotation18. (An “image plane,” as used herein, including in the claims, is a plane that is perpendicular to the optical axis at any axial image point of the imaging system.)

In order to align the image plane ofimaging system120, a spatial attitude (i.e., an orientation or angular position) of a component of the imaging system (such as a C-arm124) is changed (sometimes repeatedly), responsively to the radiographic image, until the image plane is generally parallel toplane122.

For some applications, in order to align the image plane, after generating the image, one or more apparent dimensions offin20 as shown in the image are assessed, and the spatial attitude of the component of the imaging system is changed responsively to the assessing. In general, fin20 (optionally, as represented by radiopaque markers40) will appear distorted in the image to the extent that the image plane is not parallel withplane122. The spatial attitude of the component of the imaging system is adjusted untilfin20 no longer appears distorted, indicating that the image plane andplane122 are parallel. In other words, the spatial attitude of the component of the imaging system is adjusted until an apparent shape of the fin (either of the entire fin, or of a portion thereof, such as one or more radiographic markers thereof), as shown in the radiographic image, is no longer distorted compared to an actual shape of the fin, i.e., no longer has a modified aspect ratio compared to its actual aspect ratio. Typically, the assessing and changing of the spatial attitude are repeated until a desired relationship has been obtained between the apparent dimensions and the actual dimensions of the fin.

For example, two or more apparent dimensions of the fin may be assessed, and at least one ratio between two of the two or more apparent dimensions may be assessed. Alternatively or additionally, a reference dimension of a portion of the delivery shaft may be assessed, and the one or more apparent dimensions of the fin are compared with the reference dimension. In either case, the dimensions of the fin may include one or more of the following: one or more distances between respective sets of two features of the fin (e.g., radiopaque markers40), a greatest width of the fin in a direction parallel with axis ofrotation24, and/or a greatest length of the fin in a direction perpendicular to axis ofrotation24.

For some applications, assessing comprises measuring the one or more apparent dimensions. For some applications, the one or more apparent dimensions are compared with one or more respective actual dimensions of the fin in its expanded state. For some applications, two or more apparent dimensions of the fin are assessed, and a ratio of two of the apparent dimensions are compared with a ratio of two of the actual dimensions.

After the imaging system has been properly aligned,delivery shaft24 andfin20 are withdrawn from the patient. Typically,fin20 is first retracted intoouter shaft22, by either advancingouter shaft22 distally, or withdrawingdelivery shaft24 proximally, until the fin reassumes its contracted state.

As shown inFIG. 10E, a medical device, such as a stent106 (which, optionally, comprises a stent-graft), is introduced into vasculature of the subject, typically the one or more blood vessels from which the fin was withdrawn, or one or more other blood vessels in a vicinity of the one or more blood vessels from which the fin was withdrawn. The medical device is oriented using one or more images generated by the imaging system. Because the imaging system is properly aligned, as described above, the medical device can be properly aligned, for example, specifically in the rotational dimension, using images generated by the imaging system.

For some applications, the medical device, e.g.,stent106, is rotationally oriented using the one or more images generated by the imaging system. For example, the stent may be shaped so as to define alateral opening123, and the lateral opening may be rotationally oriented using the imaging system, such as to face in a direction that is parallel to the image plane. In the exemplary deployment procedure illustrated inFIGS. 10A-F,lateral opening123 is oriented to face the opening between descendingabdominal aorta102 and left and right common

iliac arteries

100A and100B. If the imaging plane ofimaging system120 were not properly aligned as described above, the lateral opening would not be properly rotated to face the descending abdominal aorta, but instead would face another direction parallel to the misaligned imaging plane.

For some applications,stent106 includes two or moreradiopaque features124 distributed aroundlateral opening123. For some applications,lateral opening123 is oriented such that at least a portion ofradiopaque features124 are aligned with one another in the one or more images. For example, as shown inFIG. 10E,stent106 may be properly rotationally aligned whenradiopaque feature124A appears to coincide withradiopaque feature124B in the two-dimensional radiographic image (becauseradiopaque feature124A is directly aboveradiopaque feature124B when viewed in the properly-aligned image plane), and radiopaque feature124D appears to coincide withradiopaque feature124C.

For some applications, the medical device, e.g.,stent106, is delivered in a radially-compressed state within adelivery shaft130, as shown inFIG. 10E. The medical device is typically aligned while still compressed in the delivery shaft, which is generally readily rotated in the vasculature. Optionally, whendelivery shaft24 andfin20 are withdrawn, as described above, guidewire30 is left in the one or more blood vessels, and the medical device is introduced over the guidewire.

As shown inFIG. 10F, once properly aligned, the medical device, e.g.,stent106, is delivered from the delivery shaft, and transitions to a radially-expanded state. If necessary for precise alignment, the medical device typically can be further slightly rotated even after expansion thereof. For some applications,stent106 may be configured using techniques described in US Patent Application Publication 2010/0063575, which is incorporated herein by reference, such as regarding stent graft component60 thereof. For some applications, the techniques described herein are used for rotationally aligning stent graft component60 of the '575 publication, optionally in combination with other apparatus and/or methods described in the '575 publication. For some applications, additional stents (e.g., stent-grafts) are deployed in combination withstent106, either before or after deployingstent106, such as using techniques described in one or more of the patent applications incorporated hereinbelow by reference.

For some applications of the present invention, a kit is provided that comprisesendovascular tool10 and at least one medical device, such as a stent (e.g., a stent-graft). For some applications, the kit further comprisesdelivery shaft130 and/orguidewire30.

For some applications,endovascular tool10 is used to treat ananeurysm104, such as an aortic aneurism, or an aneurism of another blood vessel. For example, the aneurism may be of the sub-renal aorta, as shown inFIGS. 10A-F. For some applications, a method is provided that comprises identifying that a patient suffers from an aneurysm, such as an aortic aneurism (e.g., a sub-renal aortic aneurism), and, responsively to the identifying, endoluminally introducingendovascular tool10 responsively to the identifying, and, optionally, a medical device, such as a stent, e.g., a stent-graft. Techniques for identifying that a patient suffers from an aneurism are well known, and thus not described herein.

Althoughendovascular tool10 has sometimes been described hereinabove as being deployed in the common iliac arteries in a vicinity of a bifurcation with the descending abdominal aorta, the endovascular tool may, for some applications, also be deployed in other body lumens, such as at other branching body lumens. For example, the tool may be deployed in the aortic arch in a vicinity of one of the branches of the aortic arch, and also when placing a fenestrated stent between the common carotid artery and either the internal or external carotid artery, and an additional stent between the fenestration of the aforementioned stent and the other carotid artery.

The scope of the present invention includes embodiments described in the following applications, which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein:

- PCT Application PCT/IL2008/000287, filed Mar. 5, 2008, which published as PCT Publication WO 2008/107885 to Shalev et al., and U.S. application Ser. No. 12/529,936 in the national stage thereof, which published as US Patent Application Publication 2010/0063575
- U.S. application Ser. No. 12/529,936, which published as US Patent Application Publication 2010/0063575 to Shalev et al.
- U.S. Provisional Application 60/892,885, filed Mar. 5, 2007
- U.S. Provisional Application 60/991,726, filed Dec. 2, 2007
- U.S. Provisional Application 61/219,758, filed Jun. 23, 2009
- U.S. Provisional Application 61/221,074, filed Jun. 28, 2009
- PCT Application PCT/IB2010/052861, filed Jun. 23, 2010, which published as PCT Publication WO 2010/150208
- PCT Application PCT/IL2010/000564, filed Jul. 14, 2010, which published as PCT Publication WO 2011/007354
- PCT Application PCT/IL2010/000917, filed Nov. 4, 2010, which published as PCT Publication WO 2011/055364
- PCT Application PCT/IL2010/000999, filed Nov. 30, 2010, entitled, “Multi-component stent-graft system for implantation in a blood vessel with multiple branches,” which published as PCT Publication WO 2011/064782
- PCT Application PCT/IL2010/00101, filed Dec. 2, 2010, entitled, “Endovascular fenestrated stent-grafting,” which published as PCT Publication WO 2011/067764
- PCT Application PCT/IL2010/001037, filed Dec. 8, 2010, entitled, “Endovascular stent-graft system with fenestrated and crossing stent-grafts,”which published as PCT Publication WO 2011/070576

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.